Cannabidiol Cigarettes as Adjunctive Treatment for Psychotic Disorders – A Randomized, Open-Label Pilot-Study

Background: Psychotic disorders are associated with high rates of comorbid substance use disorders. Use of cannabis rich in tetrahydrocannabinol (THC) is linked to an increased risk of psychosis, worsening of psychotic symptoms, and an adverse course of psychotic disorders. Previous studies suggest...

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Autores principales:	Patrick Köck, Elisabeth Lang, Valerie-Noelle Trulley, Frieder Dechent, Katja Mercer-Chalmers-Bender, Priska Frei, Christian Huber, Stefan Borgwardt
Formato:	article
Lenguaje:	EN
Publicado:	Frontiers Media S.A. 2021
Materias:	cannabis schizophrenia substance-related disorders comorbidity antipsychotic agents Psychiatry RC435-571
Acceso en línea:	https://doaj.org/article/40911c74fe5941dc88784d0af54fb186
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spelling	oai:doaj.org-article:40911c74fe5941dc88784d0af54fb1862021-11-04T05:30:12ZCannabidiol Cigarettes as Adjunctive Treatment for Psychotic Disorders – A Randomized, Open-Label Pilot-Study1664-064010.3389/fpsyt.2021.736822https://doaj.org/article/40911c74fe5941dc88784d0af54fb1862021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fpsyt.2021.736822/fullhttps://doaj.org/toc/1664-0640Background: Psychotic disorders are associated with high rates of comorbid substance use disorders. Use of cannabis rich in tetrahydrocannabinol (THC) is linked to an increased risk of psychosis, worsening of psychotic symptoms, and an adverse course of psychotic disorders. Previous studies suggest oral cannabidiol (CBD) as possible novel antipsychotic agent; however, no studies evaluated the effects of smoked CBD.Objective: The main aim of the study was to clarify the antipsychotic potential of CBD used as adjunctive therapy simulating a naturalistic setting. Our trial is the first study evaluating the effects of smoked CBD-cigarettes as adjunctive therapy for psychotic symptoms.Methods: A randomized, placebo-controlled open-label trial of cigarettes containing CBD-rich cannabis (THC < 1%) as adjunctive therapy to standard psychiatric treatment was conducted (ClinicalTrials.gov identifier NCT04700930). Primary outcomes were mean scores of Positive and Negative Syndrome Scale (PANSS), Brøset Violence Checklist, the Beck's Depression Inventory (BDI), the Subjective Well-Being Under Neuroleptics Scale short form (SWN-K), and antipsychotic medication equivalent doses. Outcomes were assessed after 4 weeks of acute treatment and long-term follow-up after discontinuation of CBD-cigarettes after 25 weeks. Participants were 31 acutely psychotic patients with tobacco use disorder and a mean age of 35.1 ± 10.58 years (71% male). Comorbid cannabis use was diagnosed in 51.6%.Results: A discontinuous multilevel model revealed no significant group differences for primary outcomes. After 4 weeks of acute treatment, mean PANSS and BDI decreased in both groups, while an increase of antipsychotic medication equivalent was observed in the placebo group.Conclusions: The presented findings might suggest an antipsychotic medication sparing effect of CBD-cigarettes as adjunctive treatment of acute psychosis. However, the low number of participants did not allow for further statistical analysis. Hence, a larger study sample and a more rigorous study design (blinding of the interventional product, fixed dosing regimen) may reveal different results.Clinical Trial Registration:ClinicalTrials.gov, identifier: NCT04700930Patrick KöckElisabeth LangValerie-Noelle TrulleyValerie-Noelle TrulleyFrieder DechentKatja Mercer-Chalmers-BenderPriska FreiChristian HuberStefan BorgwardtStefan BorgwardtFrontiers Media S.A.articlecannabisschizophreniasubstance-related disorderscomorbidityantipsychotic agentsPsychiatryRC435-571ENFrontiers in Psychiatry, Vol 12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	cannabis schizophrenia substance-related disorders comorbidity antipsychotic agents Psychiatry RC435-571
spellingShingle	cannabis schizophrenia substance-related disorders comorbidity antipsychotic agents Psychiatry RC435-571 Patrick Köck Elisabeth Lang Valerie-Noelle Trulley Valerie-Noelle Trulley Frieder Dechent Katja Mercer-Chalmers-Bender Priska Frei Christian Huber Stefan Borgwardt Stefan Borgwardt Cannabidiol Cigarettes as Adjunctive Treatment for Psychotic Disorders – A Randomized, Open-Label Pilot-Study
description	Background: Psychotic disorders are associated with high rates of comorbid substance use disorders. Use of cannabis rich in tetrahydrocannabinol (THC) is linked to an increased risk of psychosis, worsening of psychotic symptoms, and an adverse course of psychotic disorders. Previous studies suggest oral cannabidiol (CBD) as possible novel antipsychotic agent; however, no studies evaluated the effects of smoked CBD.Objective: The main aim of the study was to clarify the antipsychotic potential of CBD used as adjunctive therapy simulating a naturalistic setting. Our trial is the first study evaluating the effects of smoked CBD-cigarettes as adjunctive therapy for psychotic symptoms.Methods: A randomized, placebo-controlled open-label trial of cigarettes containing CBD-rich cannabis (THC < 1%) as adjunctive therapy to standard psychiatric treatment was conducted (ClinicalTrials.gov identifier NCT04700930). Primary outcomes were mean scores of Positive and Negative Syndrome Scale (PANSS), Brøset Violence Checklist, the Beck's Depression Inventory (BDI), the Subjective Well-Being Under Neuroleptics Scale short form (SWN-K), and antipsychotic medication equivalent doses. Outcomes were assessed after 4 weeks of acute treatment and long-term follow-up after discontinuation of CBD-cigarettes after 25 weeks. Participants were 31 acutely psychotic patients with tobacco use disorder and a mean age of 35.1 ± 10.58 years (71% male). Comorbid cannabis use was diagnosed in 51.6%.Results: A discontinuous multilevel model revealed no significant group differences for primary outcomes. After 4 weeks of acute treatment, mean PANSS and BDI decreased in both groups, while an increase of antipsychotic medication equivalent was observed in the placebo group.Conclusions: The presented findings might suggest an antipsychotic medication sparing effect of CBD-cigarettes as adjunctive treatment of acute psychosis. However, the low number of participants did not allow for further statistical analysis. Hence, a larger study sample and a more rigorous study design (blinding of the interventional product, fixed dosing regimen) may reveal different results.Clinical Trial Registration:ClinicalTrials.gov, identifier: NCT04700930
format	article
author	Patrick Köck Elisabeth Lang Valerie-Noelle Trulley Valerie-Noelle Trulley Frieder Dechent Katja Mercer-Chalmers-Bender Priska Frei Christian Huber Stefan Borgwardt Stefan Borgwardt
author_facet	Patrick Köck Elisabeth Lang Valerie-Noelle Trulley Valerie-Noelle Trulley Frieder Dechent Katja Mercer-Chalmers-Bender Priska Frei Christian Huber Stefan Borgwardt Stefan Borgwardt
author_sort	Patrick Köck
title	Cannabidiol Cigarettes as Adjunctive Treatment for Psychotic Disorders – A Randomized, Open-Label Pilot-Study
title_short	Cannabidiol Cigarettes as Adjunctive Treatment for Psychotic Disorders – A Randomized, Open-Label Pilot-Study
title_full	Cannabidiol Cigarettes as Adjunctive Treatment for Psychotic Disorders – A Randomized, Open-Label Pilot-Study
title_fullStr	Cannabidiol Cigarettes as Adjunctive Treatment for Psychotic Disorders – A Randomized, Open-Label Pilot-Study
title_full_unstemmed	Cannabidiol Cigarettes as Adjunctive Treatment for Psychotic Disorders – A Randomized, Open-Label Pilot-Study
title_sort	cannabidiol cigarettes as adjunctive treatment for psychotic disorders – a randomized, open-label pilot-study
publisher	Frontiers Media S.A.
publishDate	2021
url	https://doaj.org/article/40911c74fe5941dc88784d0af54fb186
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Cannabidiol Cigarettes as Adjunctive Treatment for Psychotic Disorders – A Randomized, Open-Label Pilot-Study

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